Summary

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above
normal body temperature. Ultrasound energy may be able to kill tumor cells by heating up the
tumor cells without affecting the surrounding tissue. Implant radiation therapy uses
radioactive material placed directly into or near a tumor to kill tumor cells. Giving
ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells.

PURPOSE: This clinical trial is studying ultrasound hyperthermia therapy to see how well it
works after implant radiation therapy in treating patients with Stage III/IV cancer of the
cervix or prostate cancer with a rising prostate specific antigen (PSA) after prior local
therapy.

Primary Outcomes

Evaluate the safety and tolerability of interstitial and endocavitary ultrasound hyperthermia therapy

time frame:
baseline to completion of study

Secondary Outcomes

Measure

Evaluate the feasibility, defined as being able to administer hyperthermia at a specified temperature range and thermal dose.

time frame:
baseline to completion of study

Characterize the interstitial and endocavitary ultrasound heating technology by describing the thermal parameters including attainable temperature and thermal dose distribution and duration at the tumor treatment region.

time frame:
baseline to completion of study

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria:
Patients who are to be given HDR brachytherapy for treatment of solid tumor of the
following:
- Cervical cancer Stage III or IV OR
- Prostate cancer (with rising prostate specific antigen after prior local therapy)
Age ≥18 years
Eligible for brachytherapy as determined per clinical standard of care.
Ability to give written informed consent and willingness to comply with the requirements
of the protocol
Exclusion Criteria:
Patients who are not candidates for HDR brachytherapy
Any condition that compromises compliance with the objectives and procedures of this
protocol, as judged by the principal investigator

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Trial Details

Related Tags

A type of treatment in which body tissue is exposed to high temperatures to damage and kill cancer cells or to make cancer cells more sensitive to the effects of radiation and certain anticancer drugs.